C5 will be holding its Biosimilars Forum 2012 on January 25-26, 2012 in London, UK. C5 faculty will help attendees:
• Overcome the regulatory hurdles blocking biosimilar approval by increasing knowledge of EMA guidelines;
• Discover how the development of the FDA regulatory approval pathway will affect market access for biosimilars in the United States;
• Hear legal advice on information exchange between applicants and patent holders to establish a framework for clinical development of a biosimilar;
• Refine patent protection strategy by mastering the nuances of intellectual property rights of biosimilar applicants and innovators;
• Learn how to approach risk-benefit analysis more effectively to identify the true commercial and clinical value of a biosimilar;
• Enhance knowledge of data exclusivity and SPC regulation and get advice as an innovator on how to mitigate the threat of biosimilars; and
• Discuss the usage of biosimilars and biobetters as substitutes for original products and evaluate the implications for product liability.
In particular, C5's faculty will offer presentations on the following topics:
• Regulatory approval standards and pharmacovigilance criteria for biosimilars;
• European biosimilar approval guidelines: Interpretation, implementation and evolution;
• EMA vs. FDA: Comparing biosimilar approval pathways in Europe and the United States;
• Navigating the U.S. information and patent exchange process for biosimilars;
• Patent enforcement issues relating to biosimilars;
• Analysing the SPC regulatory landscape for biosimilars;
• Case studies and national perspectives on SPCs and U.S. patent dispute provisions;
• Clinical standards for the approval of biosimilars;
• Biosimilars in merger, licensing and collaboration agreements;
• Biosimilars vs. biobetters;
• Market access and the commercial landscape of biosimilars;
• Interchangeability and substitution of biosimilars and reference products;
• Crushing the bandwagon: Innovator companies doing biosimilars; and
• Standards for inequitable conduct in patent cases.
A pre-conference workshop on "Biosimilar Monoclonal Antibodies," will be offered from 8:30 am to 4:30 pm on January 24, 2012. The workshop will offer presentations on the following topics:
• Assessment of the European draft guidelines for similar biological medicinal products containing monoclonal antibodies;
• Anticipating outcomes of first approvals of monoclonal antibody biosimilars in highly regulated markets;
• The potential role of emerging markets and non-comparable products in driving/undermining biosimilars for the more complex biologics products, such as monoclonal antibodies, even in the highly regulated markets; and
• Interchangeability and substitution issues Will patent expiries govern biosimilar filings?
The agenda for Biosimilars Forum 2012 can be found here (conference) and here (workshop). A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference is £1599 (conference alone) or £2098 (conference and workshop). Those registering by January 6, 2012 will receive a £200 discount. Those interested in registering for the conference can do so here, by calling +44 20 7878 6888, or by faxing a registration form to +44 20 7878 6885.
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